Switching control device and manipulating part for a medical instrument

ABSTRACT

A switching control device for a medical instrument such as an electrode used in HF surgery. The switching control device comprises a connection line, designed as a switching control module for controlling various electrical operating modes of the instrument with a three-dimensionally and pressure-tightly sealed housing that is resistant to sterilization temperatures, an actuating element and fixing means to be releasably mounted within or on a manipulating part of the instrument, and module contacting means for interacting with device- or instrument-contacting means that are connected to the connection line to perform a switching control function.

FIELD OF THE INVENTION

Embodiments of the invention relate to a switching control device for amedical instrument, especially an electrode for HF surgery, and amanipulating part for an instrument of this type.

BACKGROUND

Hereinafter, the term “switching control device” denotes any switchand/or control device(s) with which an operator can switch, or controlin some other way (including in an analog way) a function of theinstrument in question, especially an energy supply thereto, a geometricconfiguration thereof or a signal transmission there-from. An“instrument” should be understood to mean any medical—surgical,therapeutic or diagnostic—instrument and “manipulating part” denotesparts or sections of an instrument of this kind, which an operator holdsin the hand and/or on which he/she performs switching or controlfunctions when the instrument is used for medical purposes.

The reusable surgical manipulating elements having an activationfunction (e.g., electrode handles for HF surgery) currently available onthe market are designed such that the switching function or theelectronic components required therefore (such as, e.g., push buttons,resistances, diodes) are mounted on a printed circuit board, which isintegrated centrally in the interior of the handles.

The electrical cable connections (litz wires) are usually soldered ontothe printed circuit board. The contact socket required for theelectrical and mechanical contacting of the instruments (e.g., monopolarelectrodes) is also attached to the printed circuit board (e.g., bysoldering). In the case of HF surgery handles, the power required foruse is thus supplied via the conductors mounted on the printed circuitboard.

Surgical manipulating elements with an activating function (e.g.,electrode handles for HF surgery) are prepared by sterilization usingmoist heat, ethylene oxide gas or gamma radiation. It is necessary toensure that the products fulfill their function over a defined periodwithout any restriction and that no safety-relevant defects posing arisk to the patient and user occur thereby. The ambient conditions(thermal, physical) of the different sterilization methods can result inthe premature failure of the products, e.g., due to the penetration offluids.

To maintain a fault-free function and exclude safety-relevant defects,it is necessary to prevent the penetration of moisture (initiated bypreparation: washing, sterilization). This is generally achieved bymechanical seals (e.g., O-rings) at the interfaces to the externalenvironment (e.g., cable outlet, button region, contact socket region onthe distal end of the handle).

The structural principles of the activating function for differentsurgical manipulating elements can sometimes differ greatly andconsequently, the maintenance of the defined lifetime in accordance withthe safety requirements can turn out very differently.

The known solutions to prevent the penetration of moisture during thepreparation, washing or sterilization of the instruments or manipulatingparts have certain systemic drawbacks:

Mechanical sealing of the numerous interfaces is difficult to achieve,especially due to material changes induced by chemical/thermalreconditioning. The sealing elements are exposed to extreme stress dueto the “tight system” and trapped air (in large hollow spaces), thermalcycling and the corresponding gas exchange in the interior of thehandles (initiated by the washing and sterilization processes). Thepenetration of moisture can cause corrosion of metallic parts(especially conductors, contacts, connections between electroniccomponents), which can result in a functional failure and, in the “worstcase,” to self-activation. Especially with HF conducting structures, thepenetration of moisture can result in corrosion initiated byelectrochemical processes, which can have extremely serious consequencesfrom both functional and safety viewpoints.

SUMMARY

It is an object of the embodiments of the invention to resolve theproblems of known manipulating parts using a new concept, whichespecially facilitates the provision of manipulating parts withunrestricted functions and the satisfaction of all safety requirementsover a required lifetime while also achieving improvements with respectto the ease of production and process reliability of the manipulatingparts.

This object is achieved according to a first aspect by a novel switchingcontrol device for medical instruments with the features describedherein and according to a second aspect by a manipulating part describedherein. Also provided is a set of medical instruments with correspondingmanipulating parts.

Embodiments of the invention include the concept of a modularimplementation of the actual manipulation function and the switchingcontrol function(s) of instruments of the type described herein. Thismodularity is such that the switching control device is designed as arelatively independent, inherently three-dimensionally enclosedswitching control module with the corresponding actuating element andcommunication means for interacting with the instrument or an associateddevice for implementing the switching/control function. The embodimentsof the invention also include providing fixing means to be releasablymounted within, or on, the manipulating part on this switching controlmodule. Moreover, the switching control module is designed to bepressure-tight and insensitive to heat such that it reliably withstandsthe prevailing ambient conditions during washing, sterilization, etc.over numerous application cycles.

The switching control module does not have its own electrical supplylead; instead, it engages its contacting means in internal electricalconnections of an instrument, which can be connected via an instrumentsupply lead to the power network.

A significant advantage of the proposed solution consists in the factthat, due to the small physical size, the residual gas content in theswitching control module can be kept very low and the stress on theparts (especially the housing) due to thermal cycling can besignificantly reduced. The manipulating parts remaining after theremoval of the switching control module do not have to have a tightdesign (i.e., the aforementioned, structurally and technologicallycomplex sealing of interfaces is no longer necessary). This results in asimple and reliable assembly technology for the novel, modularmanipulating parts.

In a preferred embodiment, the switching control module can be used in a“standardized” design, if necessary, in a plurality of different, butsystem-compatible manipulating parts or instruments—and optionally alsoas an independent unit, without spatial reference to a manipulatingpart. This facilitates further simplifications of the design andproduction processes and logistics in the hospital or surgery.

In an embodiment that offers a wide range of possible applications fromthe current viewpoint, the module contacting means comprises plug-incontact elements, especially contact pins or a plug, for engagement inconnection contacts of the manipulating part. Alternatively, themodule's contacting means can comprise a wireless transmission unit,especially a Bluetooth™, IR or ultrasound transmission unit. Inparticular, the embodiment also facilitates a stand-alone function ofthe switching control device, spatially detached from a manipulatingpart in the narrower sense.

In a further embodiment, the fixing means comprises latching means,which are especially molded onto the housing. Alternatively or incombination with, the fixing means can comprise a threaded section,which is especially molded onto the housing. It is also possible to useadditional simple fixing or connecting means in a manner known for theproduction of a releasable connection between the switching controlmodule and the manipulating part (for example, means such as bayonetlocks, sliding guides etc.).

In a particularly expedient embodiment, the actuating element can beformed from a deformable section of the housing. For example, in thecase of a switching control device comprising a push button as anactivating element, a switching spring molded into the housing of thepush button, which simultaneously forms the housing of the switchingcontrol module, can form the actuating element.

Expedient features of the manipulating part according to the embodimentsof the invention may be derived from the above statements relating tothe embodiment of the switching control module and, therefore, they willnot be repeated here. Overall, it is understood that handle-side fixingor connecting means and contacting means are designed to correspond tothe corresponding fixing or contacting means of the switching controlmodule. Where functionally possible, it is also possible to interchangefeatures, for example, to provide contact pins in the handle andcorresponding contact sockets on the switching control module. It shouldbe noted that endoscopic instruments with no manipulating part in thenarrower sense, but which can be guided and switched/controlled by anoperator are expressly considered to belong within the scope of thedisclosed embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The aforementioned advantages and expedient features can also be derivedfrom the following description of exemplary embodiments and aspects ofthe invention with reference to the drawings, in which:

FIGS. 1A to 1C are perspective views of a manipulating part according toan embodiment of the invention with a removable switching controlmodule;

FIG. 2 illustrates a longitudinal section of a push button as acomponent of the switching control module shown in FIGS. 1A to 1C;

FIG. 3 is a sketch of a further embodiment of the invention; and

FIG. 4 is a sketch of a set of medical instruments designed according tothe embodiments disclosed herein.

DETAILED DESCRIPTION

FIGS. 1A to 1C show an HF electrode handle 1 to guide an HF electrode(not shown) for HF surgery containing a removable switching controlmodule 3. The switching control module 3 has a housing 3 a with amolded-on latching hook 3 b and two push buttons 5 as actuating elementsfor each on/off switch 7 used in the housing 3 a. The switches are usedfor switching between various (electrical) operating modes of theinstrument. It should be noted that it is also possible to providerotating or sliding actuators for controlling electrical operatingparameters of the instrument instead of one or both switches.

Each switch 7 has ring-shaped inner and outer contacts 7 a, 7 b.Provided on the manipulating part 1, there is a bevelled surface section1 a for mounting the switching control module 3; in this section, thereare first recesses 1 d, which can accommodate the switch 7, and secondrecesses 1 c, which interact as fixing or latching means on the handleside with the latching hook 3 b on the switching control modules.

FIG. 2 shows a push button 10 connected to two external connectioncontacts C1, C2 arranged on a printed circuit board P of a medicalmanipulating part. The push button 10, which, in the embodiment of theinvention shown in FIGS. 1A to 1C, can be used instead of the switch 7,comprises a first housing piece 11 in the shape of a pot with a floor 11a in the shape of a spherical segment and a cylindrical wall 11 b, aring-shaped second housing piece 12 made of glass and a contact piece(mating contact) 13 placed centrically in the glass housing piece 12.The dimensions of the outer diameter of the second housing piece areselected so that it fits in the cylindrical wall 11 b of the firsthousing piece 11 with virtually no play, and a pin portion 13 a of thecontact piece 13 fits in the cylindrical bushing in its center, againwith virtually no play.

A thermal machining step creates in each case a hermetically tightsealing TS on the contact surfaces of the parts mentioned above. Thecontact piece 13 is placed in the push button 10 such that a circularcontact plate 13 b comes to lie on its inner end in a hollow space 14between the internal face of the second housing piece 12 and the floorof the first housing piece 11, and, to be precise, with a spacing belowthe dent 11 a in the floor of the first housing piece such that, onelastic depression, it touches the contact plate 13 b. This establishesa (temporary) electrical connection between the connecting contact C1,to which the contact piece 13 is connected, and the connecting contactC2, to which the conductive first housing piece 11 is connected. Thus,the dent 11 a serves as a switching spring of the push button 10 and, ina modification of the embodiment according to FIGS. 1A to 1C, candirectly replace the actuating push button or be arranged there-under.

FIG. 3 shows a further embodiment of a switching control module 3′,which (in another configuration) can be connected to a manipulating partof a medical instrument, but, in the configuration shown, is notintegrated into a handle; instead, it is manipulated by the operatorindependently to execute control functions on an endoscopic instrumentI. The signal connection takes places over a Bluetooth™ radio link and,to this end, the switching control module 3′ comprises a Bluetooth™radio transmission unit T and the instrument I comprises a correspondingreceiver unit R.

FIG. 4 is a sketch of a set SI of medical instruments I1 to I3 withdifferently designed manipulating parts 1.1 to 1.3, each comprising afixed connection line and uniformly designed receptacles for a switchingcontrol module 3. Thus, each instrument can be fitted with the sameswitching control unit, or only one single type of switching controldevice needs to be produced for all instruments and kept in store.

The embodiments of the invention are not restricted to the examplesdescribed and aspects highlighted above; instead, a plurality ofmodifications within the scope of professional practice may be made.

1-12. (canceled)
 13. A switching control device for a medical instrumentsuch as an electrode used in HF surgery, said switching control devicecomprising: a connection line, implemented as a switching control modulefor controlling various electrical operating modes of the instrumentwith a three-dimensionally and pressure-tightly sealed housing that isresistant to sterilization temperatures, an actuating element and fixingmeans to be releasably mounted within or on a manipulating part of theinstrument, and module contacting means for interacting withdevice-contacting or instrument-contacting means that are connected tothe connection line to perform a switching control function.
 14. Theswitching control device of claim 13, wherein the module contactingmeans comprises plug-in contact elements for engagement with connectioncontacts of the manipulating part.
 15. The switching control device ofclaim 13, wherein the module contacting means comprises contact pins ora plug for engagement with connection contacts of the manipulating part.16. The switching control device of claim 13, wherein the modulecontacting means comprises a wireless transmission unit.
 17. Theswitching control device of claim 13, wherein the module contactingmeans comprises a Bluetooth™ transmission unit.
 18. The switchingcontrol device of claim 13, wherein the module contacting meanscomprises an IR transmission unit.
 19. The switching control device ofclaim 13, wherein the module contacting means comprises an ultrasoundtransmission unit.
 20. The switching control device of claim 13, whereinthe fixing means comprises latching means molded onto the housing. 21.The switching control device of claim 13, wherein the fixing meanscomprises a threaded section molded onto the housing.
 22. The switchingcontrol device of claim 13, further comprising a push button.
 23. Theswitching control device of claim 13, wherein the actuating element isformed from a pressure-deformable section of the housing.
 24. Amanipulating part of a medical instrument comprising: a recess,manipulating fixing means and manipulating contacting means for thereleasable mounting and control-signal-based connection of a switchingcontrol device, said switching control device comprising: a connectionline, implemented as a switching control module for controlling variouselectrical operating modes of the instrument with a three-dimensionallyand pressure-tightly sealed housing that is resistant to sterilizationtemperatures, an actuating element and fixing means to be releasablymounted within or on the manipulating part, and module contacting meansfor interacting with said manipulating contacting means being connectedto the connection line to perform a switching control function.
 25. Themanipulating part of claim 24, wherein the manipulating contacting meanscomprises connection contacts for the engagement of plug-in contactelements of the switching control device.
 26. The manipulating part ofclaim 24, further comprising a wireless receiver unit for interactingwith a corresponding wireless transmission unit of the switching controldevice.
 27. The manipulating part of claim 24, further comprising aBluetooth™ receiver unit for interacting with a corresponding Bluetooth™transmission unit of the switching control device.
 28. The manipulatingpart of claim 24, further comprising an IR receiver unit for interactingwith a corresponding IR transmission unit of the switching controldevice.
 29. The manipulating part of claim 24, further comprising anultrasound receiver unit for interacting with a corresponding ultrasoundtransmission unit of the switching control device.
 30. The manipulatingpart of claim 24, further comprising latching means designed tocorrespond to corresponding fixing means of the switching controldevice.
 31. The manipulating part of claim 24, further comprising athreaded section designed to correspond to a corresponding threadedsection of the switching control device.
 32. A set of medicalinstruments, each with a manipulating part according to claim
 24. 33.The set of medical instruments of claim 32, wherein the manipulatingparts of each instruments have recesses containing manipulating fixingmeans and manipulating contacting means of the same kind for themounting and control-signal-based connection of the same switchingcontrol device.